Stature® STL-013-010

GUDID M681STL0130100

13mm Lordotic Spacer

ATLAS SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: M681STL0130100
• NIH Device Record Key: 2bbe03d8-6e7c-4d2c-a194-07f4c2c97bc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stature®
• Version Model Number: Stature®
• Catalog Number: STL-013-010
• Company DUNS: 140801007
• Company Name: ATLAS SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M681STL0130100 [Primary]

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

[M681STL0130100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-01

On-Brand Devices [Stature®]

• M681STL0170140: 17mm Lordotic Spacer
• M681STL0150120: 15mm Lordotic Spacer
• M681STL0130100: 13mm Lordotic Spacer
• M681STL0110080: 11mm Lordotic Spacer
• M681STL0090060: 9mm Lordotic Spacer
• M681STF0170140: 17mm Non-Lordotic Spacer
• M681STF0150120: 15mm Non-Lordotic Spacer
• M681STF0130100: 13mm Non-Lordotic Spacer
• M681STF0110080: 11mm Non-Lordotic Spacer
• M681STF0090060: 9mm Non-Lordotic Spacer